FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)

Core Viewpoint - INOVIO's Biologics License Application (BLA) for INO-3107 has been accepted by the FDA for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP), with a standard review classification assigned [1][2] Group 1: FDA Review Process - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, for INO-3107, indicating when it intends to take action on the application [2] - INOVIO filed the BLA under the accelerated approval pathway, although the FDA has raised concerns about the adequacy of information submitted for this pathway [3] Group 2: Clinical Data and Efficacy - INO-3107 has shown potential therapeutic benefits in clinical trials, with 72% of patients experiencing a 50-to-100% reduction in surgeries after one year of treatment, increasing to 86% in the second year without additional dosing [6][4] - The BLA is supported by data from a Phase 1/2 trial involving adult patients with RRP who had undergone multiple surgeries prior to treatment, demonstrating long-term clinical benefits [4][6] Group 3: Disease Background and Market Need - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to the development of benign papillomas in the respiratory tract, which can cause severe complications [5] - Current standard care involves surgical removal of papillomas, but they often regrow, highlighting the need for effective non-surgical treatment options [5] Group 4: INO-3107 and its Mechanism - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially preventing or slowing the growth of new papillomas [6][7] - The treatment has shown a strong immune response and was well tolerated in clinical trials, with mostly low-grade adverse effects reported [6][7] Group 5: Regulatory Designations and Market Access - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designation from the European Commission [8] - The CELLECTRA delivery device has been CE-marked in the EU, allowing for commercialization in regions recognizing this certification [8]